Registration Dossier
Registration Dossier
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EC number: 214-772-3 | CAS number: 1193-24-4
Endpoint summary
Administrative data
Description of key information
Oral: LD50 > 2000 mg/kg bw, male/female, rat, OECD 401, Ebert 1995
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-07-24 to 1995-08-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to OECD guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Cpb/Win:WU (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: young adult
- Weight at study initiation: males 134 - 205 g, females 121 - 141 g
- Fasting period before study: 16 hours
- Housing: conventional, sexes separated, 5 animals/Macrolon cage type III
- Diet: ad libitum, Ssniff R 10 Alleindiaet fuer Ratten
- Water: communal drinking water ad libitum
- Acclimation period: > 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES: From: 1995-07-24 To: 1995-08-14 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2 g / 10 cm3
- Amount of vehicle (if gavage): 10 cm3 / kg body weight
- Lot/batch no. : Maiskeimoel MEH 56 - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: 0.5, 1, 2, 3 4, 5, 6 hours after application, then daily; weighing: days 0, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- None (limit test)
- Preliminary study:
- Two male and two female animals were treated with 2000 mg/kg bw , as a preliminary test. Since no mortality was observed after 24 hours, three more males and females were treated with the same dose. The results were pooled and reported for the whole group of 5 animals per sex: No mortalities occurred.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None observed
- Clinical signs:
- other: None in females. None in 4/5 males. Abnormal gait, crouched position, decrease of motility, ruffled fur, staggering, and coordination disturbance (onset after 24 hours) in one male. In this animal, all symptoms (except crouched position) lasted until day
- Gross pathology:
- No signs of macroscopically detectable organ changes
- Other findings:
- - Other observations: Orange discoloration of urine (color of test substance, observed in bedding)
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The study report is adequate and reliable for risk assessment, classification and labeling.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Only a single study conducted according to guideline OECD 401 and under GLP is available. The study is considered to be relevant, reliable (Klimisch 1) and adequate for the purposes of risk assessment, classification and labelling. The LD50 in male and female rats was determined to be > 2000 mg/kg bw, since no mortality was observed (limit test).
Justification for classification or non-classification
The value for the acute oral toxicity, LD50>2000 mg/kg bw does not lead to the classification of the substance, according to the criteria for classification under Regulation (EC) No. 1272/2008, Annex I, Part 3, 3.1.2.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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